MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Difficult or Delayed Positioning (1157); Device Issue (2379); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was not reproduced during functional testing of the autopulse platform (sn (b)(4)); however, review of the archive data found the occurrence of user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error messages on the reported event date of (b)(6) 2018, thus confirming the reported event.The ua 7 recorded in the archive data is attributed to a possible improper alignment of the patient and the lifeband on the platform at the time of the event.It is also likely that these recorded events occurred during patient transport the autopulse platform is a reusable device and was manufactured on 28 jul 2010.It has exceeded its serviceable life of 5 years and is approaching 8 years old.The platform was functionally tested using good known autopulse li-ion batteries.The platform performed continuous compression using a large resuscitation test fixture without any stoppages, errors or faults observed.As part of routine service during testing, the platform was examined and found no physical damage.The platform passed all final testing criteria including the load characterization check confirming that the load cells are within specification.Note that user advisory error messages are designed into the platform when one of several conditions is detected.The error messages observed in the archive are easily clearable by user.For example, the ua 7 error message alerts the operator that the patient is out of position and not properly centered in the platform.This user advisory will persist until the patient is properly aligned.Per the autopulse user guide instruction, to clear the error message, the operator needs to pull up the lifeband until the chest bands are fully extended.Ensuring that the patient and the lifeband are aligned and then restarting the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, the cardiac arrest patient received bystander cpr for an unspecified time when the crew arrived.The autopulse platform stopped just when powered on during the deployment.The patient was removed from the platform and manual cpr was immediately performed for approximately 35 to 40 minutes until the patient was transferred to the hospital.The patient did not survived after received manual cpr.The reporter attributes the patient outcome to the patient's underlying condition and there was no delay in emergency care.No compression was provided by the autopulse.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Autopulse did not provide compressions, and did not cause or contribute to the patient's death.In this event, death is attributed to out-of-hospital cardiac arrest (ohca).Death is an expected outcome for ohca.

Event Description

The crew arrived on the scene in response to a patient in cardiac arrest.It was noted that the patient was found down for an unspecified time and was being administered bystander cpr at the time of the crew's arrival.Per report, the autopulse platform (sn (b)(4)) during deployment was unable to initialize.The platform powered on and displayed a prompt "initializing.Please pull up the lifeband and press restart." the user followed the instructions; however, was unable to clear the prompt and operate the platform for compression.Following this, the patient was removed from the platform and manual cpr was immediately performed for approximately 35 to 40 minutes until the patient was transferred to the hospital.It was further reported that the patient was pronounced dead by the attending physician at the emergency department.The cause of the patient's cardiac arrest was not specified.The reporter attributes the patient outcome to the patient's underlying condition and there was no delay in emergency care.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7386999
• MDR Text Key: 104138406
• Report Number: 3010617000-2018-00345
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1